UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003848 |
|---|---|
| Receipt number | R000004635 |
| Scientific Title | Effects of intravenous beta-blocker(landiolol) infusion after percutaneous coronary intervention for acute myocardial infarction patients. |
| Date of disclosure of the study information | 2010/08/01 |
| Last modified on | 2014/07/01 08:46:06 |
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Basic information
Public title
Effects of intravenous beta-blocker(landiolol) infusion after percutaneous coronary intervention for acute myocardial infarction patients.
Acronym
Benefit-study
Scientific Title
Effects of intravenous beta-blocker(landiolol) infusion after percutaneous coronary intervention for acute myocardial infarction patients.
Scientific Title:Acronym
Benefit-study
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effect of landiol on infarct size and clinical outcomes after percutaneous coronary intervention for acute myocardial infarction patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
estimated infarct size
Key secondary outcomes
1)Left ventricular ejection fraction
2)inflammatory markers
3)MACE
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous landiolol infusion
Interventions/Control_2
Placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with first ST elevation myocardial infarction within 12 hours from onset, who underwent successful emergency PCI resulting in TIMI3 flow.
Key exclusion criteria
1)History of old myocardial infarction or CABG
2)Left main coronary artery disease
3)Contraindication of landiolol
4)Contraindication of oral beta-blocker therapy
5)Contraindication of aspirin
6)Systolic blood pressure is 80mmHg or lower
7)Heart rate is 60/min or lower due to atrioventricular block etc.
8)Patients already taking beta-blocker
9)Severe renal and liver dysfunction
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Nishioka, MD |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Division of Cardiology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
049-228-3400
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Toyama, MD |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Division of Cardiology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
049-228-3400
Homepage URL
Sponsor or person
Institute
Division of Cardiology, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
埼玉医科大学総合医療センター
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 30 | Day |
Last modified on
| 2014 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004635
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
